System and method for breast augmentation

CROSS-REFERENCE TO RELATED APPLICATIONS

0001This application is a continuation in part of U.S. patent application Ser. No. 10/654,156, filed Sep. 3, 2003, now U.S. Pat. No. 7,169,180, and U.S. patent application Ser. No. 10/931,899, filed Sep. 1, 2004, both of which are incorporated herein by reference in their entirety.

FIELD OF THE INVENTION

0002This invention relates generally to surgical systems and methods, and more particularly to systems and methods for performing breast augmentation surgery.

BACKGROUND OF THE INVENTION

0003Breast augmentation surgery is a cosmetic procedure in which a foreign substance is placed into or under the breast to alter the size and/or shape of the breasts. Breast augmentation surgery has been performed for many years according to many different procedures. Generally, these procedures have centered on the use of a single large sack comprised of a silicone elastomer shell that is filled with a silicone gel or saline solution to give the implant a more natural appearance and feel when implanted into the patient. Although this procedure is considered to be generally safer for the patient than prior procedures, it does have some associated complications. All implants can rupture, deflate or leak. Silicone-filled implants will thereby release this foreign substance into the body. Saline-filled implants are considered preferable in that breakage will release only a sterile saline solution into the body. There is concern, however, that the saline-filled implants could support the growth of fungus and certain bacteria. Rupture or leakage would then release these potentially harmful organisms into the patient's body.

0004A significant complication that exists with both silicone-filled and saline-filled implants is that of capsular contracture. This is a condition in which abnormal scar tissue forms around the implant, resulting in a hard capsule that is abnormal in appearance and can be painful for the patient. It is a chronic condition for which there are few effective treatments that do not require additional surgery.

SUMMARY OF THE INVENTION

0005A system for breast augmentation comprises a plurality of microballoons. An injector is provided for injecting the microballoons into a breast through an incision in the breast. The microballoons have a first dimension when held by the injector and a second, larger dimension when in the breast.

0006The microballoons can comprise a flexible, substantially spherical shell defining an open interior. The open interior is filled with a sterile material such as silicone gel or saline solution. The flexible shell can be made of plastic or silicone. In a preferred embodiment, the microballoons have a diameter or largest dimension of between about 1 and about 50 mm. In another aspect, the microballoons have a diameter or largest dimension of between about 3 and about 30 mm. In still another aspect of the invention, the microballoons have a diameter or largest dimension of between about 5 and about 20 mm.

0007The injector can be any suitable device for holding a microballoon in a first, compressed dimension and then releasing the microballoon into the breast. The microballoon will expand in the breast to the second, expanded dimension. It is also possible to fill or partially fill the microballoons after they have been placed into the breast by appropriate means such as valves or injection by syringe.

0008In one aspect, the injector comprises a compression chamber for holding the microballoons in the first, compressed dimension. Structure can be provided for forcing the microballoon into the compression chamber. This structure can be vacuum structure. The vacuum structure can comprise an aperture for drawing a sufficient vacuum in the compression chamber to force the microballoon into the compression chamber. A funnel or other suitable structure can be provided for directing microballoons into the compression chamber under the force of the vacuum.

0009The compression chamber can have an open end and releasing structure can be provided for forcing the microballoon through the open end. The releasing structure can comprise a plunger moveable through the compression chamber. The injector can have an elongated tubular member that is closed at a first end and has an opening at a second end that defines the open end. The tubular member has an open interior defining, at least in part, the compression chamber. The plunger can comprise a piston and an actuating structure. The piston is slidable within the compression chamber and the actuating structure extends through an aperture in the first end. Movement of the actuating structure through the aperture will cause the plunger to move through the compression chamber to force the microballoon through the open end.

0010A tissue dissector can be provided with an elongated main body portion having a proximal end and a distal end. A pair of dissecting arms have first and second ends. The first ends are pivotally mounted to the distal end of the elongated main body portion. The dissecting arms have a first pivotal position in which the dissecting arms are substantially juxtaposed and a second pivotal position in which the dissecting arms are separated. A flexible dissecting member is connected between substantially the second ends of the dissecting arms. The dissecting member is in an extended, dissecting position when the dissecting arms are in the second pivotal position. Actuating structure is provided for moving the dissecting arms between at least the first and second pivotal positions.

0011Tensioning structure can be provided for applying pressure to the flexible dissecting member at a position between the dissecting arms. The tensioning structure can extend through the main body portion. In one aspect, the tensioning structure is an elongated tensioning rod. Gripping structure can be provided for gripping and operating the tensioning rod.

0012The actuating structure for the dissecting arms can be any suitable actuating structure. In one aspect, the actuating structure is a squeeze grip. Operation of the squeeze grip moves the dissecting arms from the first pivotal position to the second pivotal position. Biasing structure can be provided to return the dissecting arms to the first pivotal position.

0013A method for performing breast augmentation surgery can include the step of making an incision under the breast. A subcutaneous pocket is made under the breast. A tissue dissector can be inserted through the incision and used to make the subcutaneous pocket under the breast. A plurality of microballoons are then placed into the subcutaneous pocket. A compressed microballoon can be provided with a microballoon injector. The injector holds the microballoon in the compressed condition and permits insertion into the subcutaneous pocket through the incision. The injector is inserted through the incision and the microballoon is released, whereby the microballoon assumes a second, larger dimension when in the subcutaneous pocket. The procedure is repeated until a plurality of the microballoons have been released into the subcutaneous pocket.

BRIEF DESCRIPTION OF THE DRAWINGS

0014There are shown in the drawings embodiments which are presently preferred, it being understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown, wherein:

0015<figref idref="DRAWINGS">FIG. 1</figref> is a side elevation of a tissue dissector according to the invention in a first configuration.

0016<figref idref="DRAWINGS">FIG. 2</figref> is a side elevation in a second configuration.

0017<figref idref="DRAWINGS">FIG. 3(A)</figref> is a side elevation of a microballoon according to the invention.

0018<figref idref="DRAWINGS">FIG. 3(B)</figref> is a cross-section of a microballoon according to the invention.

0019<figref idref="DRAWINGS">FIG. 4</figref> is a cross-section, partially in phantom, of a microballoon injector according to the invention.

0020<figref idref="DRAWINGS">FIG. 5</figref> is a cross-section, partially in phantom, illustrating a breast augmentation procedure according to the invention.

0021<figref idref="DRAWINGS">FIG. 6</figref> is a top plan view of an alternative embodiment of a tissue dissector according to the invention, in a first configuration.

0022<figref idref="DRAWINGS">FIG. 7</figref> is a top plan view of an alternative embodiment of a tissue dissector according to the invention, in a second configuration.

0023<figref idref="DRAWINGS">FIG. 8</figref> is a side elevation of a dissecting member, partially in phantom.

0024<figref idref="DRAWINGS">FIG. 9</figref> is a top plan view of a dissecting member, partially in phantom.

0025<figref idref="DRAWINGS">FIG. 10</figref> is an exploded perspective of a portion of a dissecting member, partially in phantom.

0026<figref idref="DRAWINGS">FIG. 11</figref> is a schematic diagram of a microballoon injector according to another embodiment of the invention.

0027<figref idref="DRAWINGS">FIG. 12</figref> is a side elevation of an embodiment of a microballoon according to the invention.

0028<figref idref="DRAWINGS">FIG. 13</figref> is a side elevation of another embodiment of a microballoon according to the invention.

0029<figref idref="DRAWINGS">FIG. 14</figref> is a side elevation of another embodiment of a microballoon according to the invention.

0030<figref idref="DRAWINGS">FIG. 15</figref> is a side elevation of another embodiment of a microballoon according to the invention.

0031<figref idref="DRAWINGS">FIG. 16</figref> is a side elevation of another embodiment of a microballoon according to the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

0032There is shown in <figref idref="DRAWINGS">FIGS. 1-2</figref> a tissue dissector <b>10</b> according to the invention. The tissue dissector <b>10</b> has an elongated main body portion <b>12</b> having a proximal end <b>14</b> and a distal end <b>18</b>. A pair of dissecting arms <b>22</b> have first ends <b>26</b> and second ends <b>30</b>. The first ends <b>26</b> are pivotally mounted to the distal end <b>18</b> of the elongated main body portion <b>12</b>. The dissecting arms <b>22</b> have a first pivotal position (<figref idref="DRAWINGS">FIG. 1</figref>) in which the dissecting arms <b>22</b> are substantially juxtaposed. In a second pivotal position shown in <figref idref="DRAWINGS">FIG. 2</figref>, the dissecting arms <b>22</b> are separated.

0033A flexible dissecting member such as cable <b>34</b> is connected substantially between the second ends <b>30</b> of the dissecting arms <b>22</b>. The dissecting cable <b>34</b> is in a substantially taut and extended dissecting position when the dissecting arms <b>22</b> are in the second pivotal position shown in <figref idref="DRAWINGS">FIG. 2</figref>.

0034Actuating structure can be provided for moving the dissecting arms <b>22</b> between at least the first and second pivotal positions. The actuating structure can be a squeeze grip <b>40</b> having a handle <b>44</b> and a movable grip lever <b>48</b>. Suitable linkage is provided such that movement of the grip lever <b>48</b> in the direction shown by the arrow will cause the dissecting arms <b>22</b> to move from the first pivotal position to the second pivotal position. A biasing such as spring <b>52</b> can be provided to cause the dissecting arms <b>22</b> to return to the first pivotal position when the grip lever <b>48</b> is released. Other actuating structure is possible.

0035Movement of the dissecting arms <b>22</b> to the second pivotal position will cause the cable <b>34</b> to extend. The dissecting cable <b>34</b> can be placed under tension by appropriate tensioning structure. In one aspect, a moveable tensioning rod <b>56</b> is provided to contact the dissecting cable <b>34</b> and place the dissecting cable <b>34</b> under tension. The tensioning rod <b>56</b> can be elongated and positioned through a suitable channel in the elongated main body portion <b>12</b>. Gripping structure such as end <b>60</b> can be provided with which to manipulate the tensioning rod <b>56</b> to the extended position shown in <figref idref="DRAWINGS">FIG. 2</figref> where the dissecting cable <b>34</b> is placed under tension. The tensioning rod <b>56</b> can be retracted by movement of the end <b>60</b> away from the proximal end <b>14</b>. Other tensioning structure is possible.

0036The tissue dissector is used to form a subcutaneous pocket under the breast. The dissecting arms <b>22</b> are kept in the first pivotal position shown in <figref idref="DRAWINGS">FIG. 1</figref> to insert the distal end <b>18</b> of the tissue dissector <b>10</b> through an incision under the breast. Only a small incision need be made due to the small cross-sectional area of the tissue dissector <b>10</b> when in the first pivotal position shown in <figref idref="DRAWINGS">FIG. 1</figref>. The actuating structure is then operated to open the dissecting arms <b>22</b> to the second pivotal position shown in <figref idref="DRAWINGS">FIG. 2</figref>. The tensioning structure is operated by movement of the tensioning rod <b>56</b> to the extended position, such that the dissecting cable <b>34</b> is substantially taut. The dissecting cable <b>34</b> is of a dimension such that, when taut, it will cut tissue under the breast to form a subcutaneous pocket.

0037The open configuration shown in <figref idref="DRAWINGS">FIG. 2</figref>, while in the breast, permits the rapid formation of a subcutaneous pocket under the breast, with minimal motion of the tissue dissector. The dissecting arms <b>22</b> are then returned to the first pivotal position by a release of the grip lever <b>48</b> and return of the tensioning rod <b>56</b> to the initial positions, such that the tissue dissector <b>10</b> can easily be removed through the incision.

0038There is shown in <figref idref="DRAWINGS">FIGS. 3A-B</figref>, a microballoon <b>70</b> according to the invention. The microballoon <b>70</b> has a flexible exterior shell <b>74</b> defining an open interior that is filled by a material <b>78</b> that is either a fluid, a gel, or a gas. The microballoon <b>70</b> is thereby elastically deformable due to the flexible shell <b>74</b> and filled interior. The flexible shell <b>74</b> can be made from several suitable materials. In one embodiment, the flexible shell is made of silicone. Other polymeric materials can be used. The filling material <b>78</b> can be any suitable material, such as saline solution, hydrogen gas or air, or silicone gel. Additionally, solid or semi-solid microballoons <b>70</b> are possible as long as they are elastically deformable.

0039The microballoons <b>70</b> are preferably spherical in shape, but can also be non-spherical. According to the invention, a plurality of the microballoons <b>70</b> are implanted into or under each breast and, accordingly, the dimensions of the microballoons <b>70</b> are much smaller than current breast implants. In a preferred embodiment, the microballoons have a diameter or largest dimension of between about 1 and about 50 mm. In another aspect, the microballoons have a diameter or largest dimension of between about 3 and about 30 mm. In still another aspect of the invention, the microballoons have a diameter or largest dimension of between about 5 and about 20 mm, and can be between 10-15 mm.

0040The microballoons are mostly spherical and may be either completely filled or partially filled. The microballoons can be comprised of an outer shell of a synthetic polymer, possibly silicone based. The microballoons are also comprised of an inner compartment of a gas, liquid, gel, which occupies a volume of the interior in a range that will produce microballoons filled to various fractions of completely full. In one embodiment, the microballoon is 75% filled relative to volumetric capacity (<figref idref="DRAWINGS">FIG. 13</figref>), in another it is 50% filled (<figref idref="DRAWINGS">FIG. 14</figref>) and in yet another it is 20% filled (<figref idref="DRAWINGS">FIG. 15</figref>), and in another it is 10% (<figref idref="DRAWINGS">FIG. 16</figref>). There are also microballoons that may be 100% filled (<figref idref="DRAWINGS">FIG. 12</figref>). In the microballoons that are less that 100% filled, the outer shell will take on a mostly non spherical configuration, such as plate like, oblong, dimpled, curved, waved, asymmetric and irregular.

0041An injector assembly for injecting a microballoon into a subcutaneous pocket can include an injector having an elongated delivery portion with a delivery chamber, where the delivery chamber has an outlet. At least one microballoon is positioned in the injector. Structure can be provided for driving the microballoon through the outlet of the delivery chamber into the subcutaneous pocket. In one embodiment, an injector can be used to hold at least one microballoon <b>70</b> in a compressed position with a first, compressed dimension, and to release the microballoon when in the breast to permit the microballoon to expand to a second, larger dimension in the subcutaneous pocket. In this manner, the microballoon <b>70</b> can be inserted into the subcutaneous pocket through a smaller incision. One such injector <b>90</b> is shown in <figref idref="DRAWINGS">FIGS. 4-5</figref>. The structure for holding the microballoon <b>70</b> in a first, compressed dimension can be any suitable structure, but in one aspect is a compression chamber <b>94</b> into which the microballoon <b>70</b> is inserted. The microballoon <b>70</b> when inserted in the compression chamber <b>94</b> assumes an elongated, deformed shape (indicated by phantom lines <b>70</b>A in <figref idref="DRAWINGS">FIG. 4</figref>). The extent of compression can vary. In the case of spherical microballoon <b>70</b>, it is preferable that the microballoon be compressed to 10-90% of the expanded diameter. In one aspect, the microballoon is compressed to about 50% of the expanded diameter.

0042The injector <b>90</b> can be an elongated tubular member having a housing <b>100</b> and an open interior <b>104</b>. The compression chamber <b>94</b> can be formed in part by the housing <b>100</b>. The manner in which the microballoons <b>70</b> are loaded into the injector <b>90</b> can vary. A manipulator can be used to apply a mechanical force to the microballoons <b>70</b> to force them into the compression chamber <b>94</b>. In another aspect, a vacuum source is applied to a vacuum fitting <b>98</b> such that a sufficient force of vacuum is used to draw the microballoons <b>70</b> into the compression chamber <b>94</b>.

0043Suitable structure can be utilized to guide the microballoons <b>70</b> through an opening <b>108</b> in the second end <b>106</b> of the housing <b>100</b>. Structure such as detachable funnel <b>112</b> can be provided to assist and direct the microballoon <b>70</b>B (dashed lines in <figref idref="DRAWINGS">FIG. 4</figref>) into the opening <b>108</b>.

0044Releasing structure is provided for releasing the microballoon <b>70</b> from the injector <b>90</b> into the subcutaneous pocket under a breast to permit the balloon to expand in the pocket to the second, expanded dimension. Any suitable structure can be used. In one aspect, a plunger <b>116</b> is movable within the open interior <b>104</b> of the housing <b>100</b>. An actuating structure <b>120</b> such as an elongated rod can extend through a suitable opening in the first end <b>102</b> of housing <b>100</b>. A head <b>124</b> can be provided to facilitate manipulation by hand.

0045The microballoon is drawn into the injector <b>90</b> to the position shown by the microballoon <b>70</b>A using funnel <b>112</b>. In this position, the microballoon is in a first, compressed shape. The funnel <b>112</b> is then removed. The injector <b>90</b> is then inserted through the incision under the breast into the subcutaneous pocket <b>130</b> (<figref idref="DRAWINGS">FIG. 5</figref>). The releasing structure such as plunger <b>116</b> is then manipulated as by actuating structure <b>120</b> to push the microballoon <b>70</b> into the subcutaneous pocket <b>130</b> as shown in <figref idref="DRAWINGS">FIG. 5</figref>. The microballoon will then expand to the second, expanded dimension.

0046The number of microballoons <b>70</b> that are implanted into the breast or other cosmetic site can vary. At least 3 microballoons are necessary. In one aspect, the number varies from about 3 to about 3000 microballoons. Alternatively, there can be between 3-2000 microballoons. There can be between 3-1000 microballoons. In another aspect, between about 50 and about 300 microballoons are used. The number will depend in part on the size of the patient, the amount of augmentation that is desired, and the shape and size of microballoons <b>70</b>. The microballoons <b>70</b> can be of the same size or different sizes. The invention can be used to perform cosmetic augmentations at a plurality of cosmetic sites. Suitable cosmetic augmentation sites can include the breast, buttock, calf, pectoral area, and upper arm (triceps and biceps). The number of microballoons that are necessary will depend in part on the site of cosmetic augmentation and the volume of the subcutaneous pocket that is to be filled for that cosmetic augmentation.

0047The plurality of microballoons <b>70</b> in the subcutaneous pocket <b>130</b> provides for a more natural shape and appearance. Additionally, because the microballoons <b>70</b> are free to move slightly within the subcutaneous pocket <b>130</b>, it is believed that the likelihood of severe scarring will be reduced. Also, the microballoons <b>70</b> will more readily conform to the shape of the subcutaneous pocket <b>130</b> than does a larger implant.

0048There is shown in <figref idref="DRAWINGS">FIGS. 6-10</figref>, an alternative embodiment of a tissue dissector according to the invention. The tissue dissector <b>150</b> has an elongated main body portion <b>154</b>, having a proximal end <b>158</b> and a distal end <b>162</b>. A pair of dissecting arms <b>166</b> have first ends <b>168</b> and second ends <b>172</b>. The first ends <b>168</b> are pivotally mounted to the distal end <b>162</b> of the elongated main body portion <b>154</b>. The dissecting arms <b>166</b> have a first pivotal position (<figref idref="DRAWINGS">FIG. 6</figref>) in which the dissecting arms <b>166</b> are substantially juxtaposed. In a second pivotal position shown in <figref idref="DRAWINGS">FIG. 7</figref>, the dissecting arms <b>166</b> are separated.

0049A flexible dissecting member <b>178</b> is connected substantially between the second ends <b>172</b> of the dissecting arms <b>166</b>. The dissecting member <b>178</b> is in an extended dissecting position when the dissecting arms <b>166</b> are in the second pivotal position shown in <figref idref="DRAWINGS">FIG. 2</figref>. Actuating structure such as the squeeze grip <b>180</b> having a handle <b>184</b> and a movable grip lever <b>188</b> can be provided. Suitable linkage can be provided such that movement of the grip lever <b>188</b> will cause the dissecting arms <b>166</b> to move from the first pivotal position to the second pivotal position. A biasing such as spring <b>192</b> can be provided to cause the dissecting arms <b>166</b> to return to the first pivotal position when the grip lever <b>188</b> is released. Other actuating structure is possible.

0050The dissecting member <b>178</b> can be comprised of a number of links <b>194</b> connected to junction members <b>196</b>. The links <b>194</b> are engaged to the junction members <b>196</b> through appropriate pins <b>198</b> or other suitable structure. The pins <b>198</b> permit each link <b>194</b> to pivot relative to the junction members <b>196</b>. In this manner, the dissecting member <b>178</b> is flexible and can be positioned from the position shown in <figref idref="DRAWINGS">FIG. 6</figref> to the position shown in <figref idref="DRAWINGS">FIG. 7</figref>. A distal link <b>200</b> permits the adjoining links <b>194</b> to pivot to the juxtaposed position shown in <figref idref="DRAWINGS">FIG. 6</figref>.

0051The dissecting member <b>178</b> must not flex toward the distal end <b>162</b> of the elongated main body portion <b>154</b> during the tissue dissection operation. The junction members <b>196</b> are constructed so as to restrict inward flexing of the dissecting member <b>178</b>. The structure to prevent this flexing can take various forms and embodiments. In the embodiments shown in <figref idref="DRAWINGS">FIGS. 8-10</figref>, the junction members <b>196</b> are provided with a stop <b>204</b>. Adjacent links <b>194</b> have protrusions <b>208</b> which engage the stop <b>204</b> to prevent the inward flexing of the dissecting member <b>178</b>. Similar protrusions <b>208</b> and stops <b>204</b> can be provided on other links <b>194</b> to prevent the inward flexing of the dissecting member <b>178</b>. Pins <b>198</b> or other suitable structure can be provided to pivotally engage the links <b>194</b> to the junction members <b>196</b>. Pins <b>198</b> can extend through suitable apertures <b>218</b>. A distal link <b>200</b> is constructed to permit positioning of the flexible member <b>178</b> in the juxtaposed and extended positions shown in <figref idref="DRAWINGS">FIGS. 6-7</figref>.

0052There is shown in <figref idref="DRAWINGS">FIG. 11</figref> an injector <b>220</b> according to an alternative embodiment of the invention. The injector <b>220</b> has an elongated delivery portion <b>224</b> comprising a delivery chamber <b>228</b>, the delivery chamber having an outlet <b>232</b>. The delivery portion <b>224</b> can be any suitable shape such as straight, curved or coiled in shape, but should provide for the storage and sequential injection of microballoons. Microballoons <b>240</b> are positioned in the injector in the delivery portion <b>224</b>. Any number of microballoons <b>240</b> can be provided in the delivery chamber <b>228</b>. A single microballoon <b>240</b> can be provided, however, to facilitate and speed the injection process between 2-30 or more microballoons <b>240</b> are provided in a single injector. Delivery structure is provided for driving the microballoons <b>240</b> through the outlet <b>232</b> of the delivery chamber into the subcutaneous pocket <b>244</b>. The delivery structure can be any suitable structure for driving the microballoons <b>240</b> through the outlet <b>232</b>, such as a plunger moveable through the delivery chamber <b>228</b> to drive the microballoon through the outlet <b>232</b>. The plunger can have a piston <b>248</b> and an actuating structure <b>252</b>, which can be an arm with a manual manipulator such as a finger grip <b>254</b>. The piston <b>248</b> is slidable within the delivery chamber and the actuating structure extends through an aperture in the injector, whereby movement of the actuating structure <b>252</b> through the aperture will cause the piston <b>248</b> to move through the delivery chamber <b>228</b> to drive the microballoons through the outlet <b>232</b> and into the subcutaneous pocket. The plunger can be removable to permit reuse. Alternatively, the delivery structure can be electronic or motorized. The interior wall of the delivery chamber <b>228</b> can be provided with a reduced friction lining, said as graphite, silicone, or polytetrafluoroethylene. The injector assembly including the injector <b>220</b> with microballoons <b>240</b> positioned in the injector can be provided within a hermetically sealed, sterile packaging container, such that the injector will be ready for use in the operating room.

0053The components of the invention are preferably made of surgical grade materials such as plastics and stainless steel. Various modifications will be apparent.

0054This invention can be embodied in other forms without departing from the spirit or essential attributes thereof. Accordingly, reference should be had to the following claims, rather than to the foregoing specification, as indicating the scope of the invention.